Symptomtext
leaking occurred between the needle and the cartridge when the plunger was depressed during administration with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from a pharmacist via Agency (Reference number- 00779083) and transmitted to Sanofi on 21-Sep-2021. This case involves a 74-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was leaking occurred between the needle and the cartridge when the plunger was depressed during administration (needle issue). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 17-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AC, expiry date 30-Jun-2022) via intramuscular route in the deltoid NOS prophylactic vaccination. It was an actual medication error due to needle issue (latency: same day). It was reported when giving FLUZONE HIGH-DOSE QUADRIVALENT to a patient, the majority of the vaccine leaked out between the needle and the cartridge. The leaking occurred between the needle and the cartridge when the plunger was depressed during administration. The pharmacist asks if the vaccine was valid or if the patient should be revaccinated. At time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.